Abstracts For Merck & Co., Gilead And AbbVie Look Promising, Says ISI

October 1, 2014

By Riley McDermid, BioSpace.com Breaking News Sr. Editor

The pharmaceutical companies that have previewed abstracts of drugs that they will be presenting to the American Association for the Study of Liver Disease (AASLD) next month are looking good for investors, said an analyst with ISI Group Wednesday.

Merck & Co., Inc. , Gilead Sciences, Inc. and AbbVie have all previewed abstract releases for the AALSD 2014 annual meeting. Included in these were some very promising study results and updates on drugs Wall Street has been keeping a close eye on, wrote Mark Schoenebaum, a biotech and pharmaceuticals analyst, in a note to investors today.

“While the abstracts today do not contain any data for short-duration regimens for triplet combinations of drugs (with Sovaldi), there were several other interesting tidbits that we found,” he wrote. “For Merck, there is no data from the triplet combination with Sovaldi online today. “We still expect that MRK will have data from the triplet, including some data from the 4-wk duration, at AASLD, however,” wrote Schoenebaum.

Merck’s abstracts show that the combination of MK-5172 and MK-8472 without ribavirin for 12 weeks “appears to have good efficacy” in GT1 patients with cirrhosis and prior null responders to PEG/ribavirin -> SVR12 rates of around 90 to 95 percent.

“Merck's next generation NS5a (MK-8408) appears potent in vitro (in replicons) in both GT1a and GT3,” added Schoenebaum.

As for Gilead, it told analysts it plans to present at AASLD pooled Phase 2 and Phase 3 data from around 500 patients with compensated cirrhosis treated with ledipasvir/sofosbuvir +/- ribavirin. “[Of those] 118 patients [were] having received ledipasvir/sofosbuvirwithout ribavirin for 12 weeks,” wrote Schoenebaum. “Today's abstract has little data on efficacy, however.”

Gilead's next generation NS5a, GS-5816, at the dose being studied in Phase 3 trials (100 mg) in combination with Sovaldi and without ribavirin for 12 weeks had “good efficacy” in GT3 patients -> SVR of around 96 percent.

“The same combination, Sovaldi + GS-5816 without ribavirin for 12 weeks in GT2 patients had SVR rate of only 88 percent,” wrote ??, while in contrast, ”Sovaldi + GS-5816 without ribavirin for eight weeks had SVR12 of only 90 percent.”

AbbVie presented abstracts that showed good efficacy for both the next-gen PI and NS5a (ABT-493 and ABT-503 respectively) in 3-day monotherapy studies in GT1 patients, at approximately -4 log drops for each, said the report.

Bristol-Myer was also notable, wrote Schoenebaum, because “the triple combination of daclatasvir/asunaprevir and BMS'325 (BMY's next generation regimen) for 12 weeks in GT1 null responders achieved SVR12 of 91 percent.”